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Trial registered on ANZCTR


Registration number
ACTRN12625000119493
Ethics application status
Approved
Date submitted
25/10/2024
Date registered
3/02/2025
Date last updated
3/02/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for Plasmodium vivax malaria in Nansang Township, Southern-Shan State, Myanmar
Scientific title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for Plasmodium vivax malaria in patients 6 years and older in Nansang Township, Southern-Shan State, Myanmar
Secondary ID [1] 313242 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasmodium falciparum malaria 335543 0
Plasmodium vivax malaria 335727 0
Condition category
Condition code
Infection 332114 332114 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum and vivax malaria. The study will be conducted from 01 April 2025 to 31 Mar 2026 in Nansang Township, Southern- Shan State, Myanmar People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with oral administration of artemether-lumefantrine tablets containing 20 mg base of artemether and 120 mg base of lumefantrine for uncomplicated Plasmodium falciparum malaria. Dosage will be 4 tablets for adult and 2 tablets for children twice a day and monitored for 28 days. Oral chloroquine with dosage will be 25mg base/kg once a day over 3 days: 10mg/kg/day, 10mg/kg/day, 5mg/kg/day for Plasmodium vivax malaria and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of direct clinical observation assessments, the patients will be classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug(s). Polymerase Chain Reaction (PCR) analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection for both P. falciparum only.
Intervention code [1] 329821 0
Treatment: Drugs
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339705 0
The primary outcomes are assessed as composite. Those are
(a) early treatment failure,
(b) late clinical failure,
(c) late parasitological failure or
(d) an adequate clinical and parasitological response.
Timepoint [1] 339705 0
Primary time points for
(a) early treatment failure will be 3 days after treatment
(b) late clinical failure, "any day between day 4 and day 28 after treatment
(c) late parasitological failure, " any day between day 7 and day 28 after treatment and
(d) an adequate clinical and parasitological response, "28 days after treatment".
Primary outcome [2] 339890 0
Malaria parasite recrudescence
Timepoint [2] 339890 0
Time point will be any day between day of re-appearance of malaria parasite and day 28 after treatment.
Secondary outcome [1] 440951 0
This is composite secondary outcome specifying the frequency and nature of adverse events/ serious adverse events, Eg. Abdominal pain, asthenia, cough, diarrhoea, dizziness, fever, headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting for adverse events. Examples of serious adverse events are hospitalization, prolong hospital stay, permanent disability, life threatening, death, congenital or birth defect,
Timepoint [1] 440951 0
Observations of adverse events/serious adverse events for 28 days follow-ups on day 1, 3, 7, 14, 21 and 28 and any day reported by the patients.

Eligibility
Key inclusion criteria
• patients aged 6 year and above;
• mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/µl asexual form detected by microscopy), or P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms);
• presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 h;
• ability to swallow oral medication;
• ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
• informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years of age and
• informed assent from any minor participant aged from 12 to 17 years of age.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• presence of signs of severe falciparum malaria according to the definitions of WHO;
• mixed or mono-infection with another Plasmodium species detected by microscopy.
• Body weight under 20 kg;
• presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
• regular medication, which may interfere with antimalarial pharmacokinetics;
• history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The WHO excel programme will be used for data management and analysis . Data will be analysed by two methods: the Kaplan-Meier method and per-protocol analysis.
The final analysis will include:
• a description of all patients screened and the distribution of reasons for non-inclusion in the study;
• a description of all the patients included in the study;
• the proportion of adverse events and serious adverse events in all the patients included in the study;
• the proportion of patients lost to follow-up or withdrawn, with 95% confidence intervals and a list of reasons for withdrawal;
• the cumulative incidence of success and failure rates at day 28, PCR-uncorrected and PCR-corrected; and
• the proportion of early treatment failure, late clinical failure, late parasitological failure and adequate clinical and parasitological response at day 28/42, with 95% confidence intervals, PCR-uncorrected and PCR-corrected.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 26654 0
Myanmar
State/province [1] 26654 0
Southern-Shan State

Funding & Sponsors
Funding source category [1] 317686 0
Other
Name [1] 317686 0
WHO
Country [1] 317686 0
Switzerland
Primary sponsor type
Other
Name
WHO Mekong Malaria Elimination Program
Address
Country
Cambodia
Secondary sponsor category [1] 320021 0
Government body
Name [1] 320021 0
Ministry of Health
Address [1] 320021 0
Country [1] 320021 0
Myanmar

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316384 0
Institutional Review Board, Department of Medical Research
Ethics committee address [1] 316384 0
Department of Medical Research, No.5 Ziwaka Road, Dagon Township. Yangon 11191
Ethics committee country [1] 316384 0
Myanmar
Date submitted for ethics approval [1] 316384 0
19/08/2024
Approval date [1] 316384 0
01/09/2024
Ethics approval number [1] 316384 0
Ethics/DMR/2021/013/Amend_2/2024
Ethics committee name [2] 316949 0
SEARO Research Ethics Committee (SEARO-ERC)
Ethics committee address [2] 316949 0
World Health House, Indraprastha Estate, Mahatma Ghandi Marg, New Delhi-11001, India
Ethics committee country [2] 316949 0
India
Date submitted for ethics approval [2] 316949 0
08/01/2025
Approval date [2] 316949 0
27/01/2025
Ethics approval number [2] 316949 0
2025.2.Mya

Summary
Brief summary
This study aims to assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for Plasmodium vivax malaria. The study will be conducted in Nansang Township, Southern- Shan State, Myanmar. This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with artemether-lumefantrine for uncomplicated P. falciparum malaria and chloroquine phosphate for P. vivax and monitored for 28 days. Febrile patients with uncomplicated P. falciparum and P. vivax malaria attending the study clinic, who are aged 6 years and above will be enrolled. Sample Size will be 80 patients for each drug. Clinical and parasitological parameters will be monitored over a 28-days follow- up period for artemether-lumefantrine for uncomplicated P. falciparum malaria and chloroquine phosphate for P. vivax, to evaluate drug efficacy and safety of respective drugs.

The study hypothesis is that efficacy of (a) artemether-lumefantrine for uncomplicated P. falciparum malaria in term of adequate clinical and parasitological response is higher than 94 % and (b) chloroquine phosphate for P. vivax malaria in term of adequate clinical and parasitological response is higher than 90 %. The treatments for both malaria infections are still safe.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137726 0
Dr Moe Kyaw Myint
Address 137726 0
Department of Medical Research (Pyin Oo Lwin Branch), Ward No. (16), Pyin Oo Lwin township, 05081, Mandalay Region, Myanmar
Country 137726 0
Myanmar
Phone 137726 0
+959402751359
Fax 137726 0
Email 137726 0
[email protected]
Contact person for public queries
Name 137727 0
Moe Kyaw Myint
Address 137727 0
Department of Medical Research (Pyin Oo Lwin Branch), Ward No. (16), Pyin Oo Lwin township, 05081, Mandalay Region, Myanmar
Country 137727 0
Myanmar
Phone 137727 0
+959402751359
Fax 137727 0
Email 137727 0
[email protected]
Contact person for scientific queries
Name 137728 0
Moe Kyaw Myint
Address 137728 0
Department of Medical Research (Pyin Oo Lwin Branch), Ward No. (16), Pyin Oo Lwin township, 05081, Mandalay Region, Myanmar
Country 137728 0
Myanmar
Phone 137728 0
+959402751359
Fax 137728 0
Email 137728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.